HIBCC Industry News
Although our scope has expanded beyond the initial HIBC labeling mandate issued 30 years ago, we have continued to emphasize ‘safety first’ through the years.
As such, the Health Industry Business Communication Council has an important advocacy and educational role in today’s healthcare industry. We are proud to act as the forum through which consensus can be reached as all parties work together to ensure a safer, more efficient industry.
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The Saudi Food and Drug Authority (SFDA) has released its “Guidance on Requirements for Unique Device Identification (UDI) for Medical Devices” designating HIBCC as an Issuing Entity. The initial release date was April 8th, 2019. To view the full guidance document click here. To learn more about UDI contact HIBCC at firstname.lastname@example.org read more →
On April 26th, 2019 the FDA published the finalized UDI guidance document for Convenience Kits. The draft was previously published in 2016. To view the complete guidance document click here. To learn more about UDI contact HIBCC at email@example.com read more →
Create, Calculate, and Confirm UDI Information with HIBCC’s suite of cloud-based tools. How do I Create a UDI? This on line utility will generate a UDI from the product information you enter. In combination with your HIBCC LIC the Creator tool will provide you with the correct data combination for printing on packages and to.. read more →
The GMDN, the de facto global standard for identifying the world’s millions of medical devices, has been made freely available to all users for the first time on 1st April 2019. Click here to view the GMDN press release. read more →
Click here to view the FDA’s guidance for Unlockling a UDI Record in the GUDID. read more →
Medical Technology Association of Australia (MTAA) releases final submission to the “TGA Consultation: Proposal to introduce a UDI system for medical devices in Australia. To view the document click here. To learn more about UDI click here or contact HIBCC at firstname.lastname@example.org. read more →
- 04 Dec 2019European Commission releases updated EUDAMED Data Dictionary
- 05 Nov 2019HIBC Basic UDI-DI Guidance and Generator Now Available to Meet European Union Requirements
- 30 Oct 2019Important Notice to HIBCC Labelers
- 30 Oct 2019European Commission confirms two year delay for the launch of EUDAMED. Labeling deadlines are not affected by this delay.
- 11 Oct 2019The HIBC UDI-Builder is now available. This tool will allow you to create, calculate, confirm, and collect UDIs.